The present invention relates to an implant for the pelvis and, more particularly, to an implant which can be held in place without suturing.
Pelvic floor disorders include cystocele, rectocele, enterocele and uterine and vaginal prolapse. These disorders are often a consequence of weakness or damage to pelvic muscles and ligaments, caused by childbearing, hysterectomy, connective tissue defects, atrophy, or physical injury. Two basic approaches to remedying this condition have been the use of a removable device known as a pessary, or surgery to replace or repair parts of the pelvic supporting structures.
A pessary is a vaginal insert, having a specified geometric configuration such as, for example, a cube or a donut, which can be temporarily placed in the vaginal canal. Examples of such devices are disclosed in U.S. Pat. No. 6,645,137; U.S. Pat. No. 6,189,535, and many others.
The surgical approach includes reconstruction of the damaged support tissue using sutures or replacement of the support tissue with an implant or device. An example of such a device is disclosed in U.S. Pat. No. 6,786,861 to Pretorius. The device disclosed therein is a sling having a flexible elongate member and a distensible portion, and is configured to be inserted dorsally between the urethra and pelvic bone, with ends of the elongate member attachable to retropubic or ischial structures. Another such device is disclosed in U.S. Pat. No. 6,755,781 to Gellman. The device disclosed therein is a medical sling having one or more cuts are disposed in the material. The cuts on the sling provide open areas to permit tissue ingrowth and crosslinking when the sling is implanted inside the body of the patient. These types of slings and supporting devices are configured to treat urinary incontinence rather than prolapse, and as such, they are generally located under the urethra or bladder neck.
Other devices for implantation within a pelvis are described. U.S. Pat. No. 6,592,515 to Thierfelder, for example, discloses an implant useful for a sacral colpopexy procedure for treating vaginal prolapse. The implant includes tissue engagement portions, which are configured for anchoring the implant into bone. World Publication WO 00/27304 to Ory et al. discloses a suspension device for treating prolapse and urinary incontinence, including a suspension cord, non-absorbable material, and anchoring parts which are designed to be fixed by suturing or stapling means to implanting walls.
All of these devices require suturing to anchor the device to the anatomical structures within the pelvis. This leads to difficulties and potential complications, as sharp needles must be placed deep within the pelvis into an area which is difficult to access. Furthermore, the stability of these implants depends on the strength of the suture, a material which can sometimes tear, and on the strength of the supporting ligaments, which may also be weak due to disease, old age, or wear from childbirth. The sutures are inflexible, and cannot accommodate dynamic pressures from the abdomen above. Finally, the use of sutures requires sharp corners or edges on the implant material, which are not suited to the contoured shape of the anatomy of the pelvis.
There is thus a widely recognized need for, and it would be highly advantageous to have, a surgical implant devoid of the above limitations.